EMEA-000609-PIP01-09-M03 - paediatric investigation plan

Recombinant human glutamic acid decarboxylase (rhGAD65)

Key facts

• Active Substance:
  Recombinant human glutamic acid decarboxylase (rhGAD65)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0441/2021
• PIP number:
  EMEA-000609-PIP01-09-M03
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of type I diabetes mellitus
• Route(s) of administration:
  Intralymphatic use
• Contact for public enquiries:

  Diamyd Medical AB

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2021

Decision

P/0441/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human glutamic acid decarboxylase (rhGAD65) (EMEA-000609-PIP01-09-M03)

AdoptedReference Number: EMA/534827/2021